{"id":1399,"date":"2024-09-23T15:32:15","date_gmt":"2024-09-23T07:32:15","guid":{"rendered":"https:\/\/flcube.com\/?p=1399"},"modified":"2024-10-25T09:25:33","modified_gmt":"2024-10-25T01:25:33","slug":"sanofis-sarclisa-secures-fda-approval-for-first-line-multiple-myeloma-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=1399","title":{"rendered":"Sanofi’s Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment"},"content":{"rendered":"\n

Sanofi (EPA: SAN<\/a>; NASDAQ: SNY<\/a>) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib, lenalidomide, and dexamethasone (VRd), for adult patients with newly diagnosed MM who are not eligible for transplant.<\/p>\n\n\n\n

The FDA’s decision was supported by the positive results from the IMROZ Phase III study, which demonstrated that the combination of Sarclisa with VRd significantly improved progression-free survival (PFS) compared to VRd alone. The median PFS for the Sarclisa VRd combination was not reached at 59.7 months, compared to 54.3 months for VRd alone, indicating a 40% reduction in the risk of disease progression or death.<\/p>\n\n\n\n

This latest indication follows Sanofi’s previous approvals for Sarclisa in the US, which included its initial approval in 2020 for use in combination with pomalidomide and dexamethasone (pom-dex) as a third-line MM treatment, and in 2021 for use with carfilzomib and dexamethasone (Kd) as a second-line MM treatment. While Sarclisa has not yet received approval in China, the drug is currently under review by the National Medical Products Administration. – Fineline.com<\/a><\/p>\n\n\n\n

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Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA)…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,29,931,867,15,147],"class_list":["post-1399","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-combination-therapy","tag-epa-san","tag-nasdaq-sny","tag-product-approvals","tag-sanofi"],"yoast_head":"\nSanofi's Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). 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